European Commission Q&A on the Interplay Between the Clinical Trials Regulation And GDPR


October 2019
Reprinted with permission.

In response to the opinion of European Data Protection Board (‘‘EDPB’’), the European Commission has issued question and answers on the interplay between the Clinical Trials Regulation (‘‘CTR’’) and the General Data Protection Regulation (‘‘GDPR’’) (‘‘Q&A’’).1 The non-binding Q&A offers some additional clarifications for data processing within clinical trials. However, the Q&A also falls short in other respects. In particular, it omits some core issues, deferring to national data protection authorities instead.

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